Lead by example and promote the criticality of strict compliance adherence at Cogmedix.

Lead in the training of personnel, including customers and suppliers on workmanship and quality standards.

Compliantly implement and maintain Cogmedix procedures.

Collaborate with Program Managers, Manufacturing Engineers and other departments to analyze customer ECO’s and ensure effective implementation to the production floor through proper use of the Cogmedix ECO process.

As part of the ECO Process and new proposal review, oversee the management of the customer BOM structure, creation of part numbers and structuring of Supplier Relationships and costs. Define PP/PA/Phantom, Commodity codes, documentation packages commodity and Work Instruction evaluation.

As part of the ECO Process, oversee the generation and updating of DMR Indexes to ensure accuracy.

Working with all internal groups, identify trends and process gaps and suggest and assist in the implementation of corrective actions and process improvements.

Collaborate with internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs.

Oversee and ensure prompt MQE responses to manufacturing floor quality issues, taking appropriate action within the Cogmedix Quality System and continually building strong rapport with customers and suppliers.

Oversee the development and approvals of optimal work order routings and Device History Records.

Review redlined documentation and review prior to sign off.

Provide support in the development of Nonconformance documentation.

Lead and oversee complex troubleshooting efforts. Lead Manufacturing Quality Engineers in the generation of Rework Instructions and review and approve prior to implementation. Generate the more complex Rework Instructions and assist when needed.

Lead and oversee the development and deployment of Lean Manufacturing Cells.

Working with the Quality Department, support the development of quality and inspection plans.

Bachelor’s degree in science, engineering, or manufacturing discipline. Eight or more years of related manufacturing experience and technical document control may be considered in lieu of certain educational requirements.